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For BPC-157, the agency cited the potential for immunogenicity, peptide-related impurities, problems characterizing the active ingredient, and a lack of safety data for the proposed routes of administration
The critical limitation for both compounds is the same: evidence is preclinical, human clinical data is either minimal (BPC-157) or nonexistent (KPV), and both are sourced through unregulated markets where product quality cannot be guaranteed
BPC-157 dispensed by a 503A pharmacy under a patient-specific prescription is legal in every U.S
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